TYSHAK NUCLEUS

K121859 · NuMED, Inc. · DQY · Aug 31, 2012 · Cardiovascular

Device Facts

• Record ID: K121859
• Device Name: TYSHAK NUCLEUS
• Applicant: NuMED, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 31, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis. - A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Device Story

Tyshak NuCLEUS™ Catheter is a balloon catheter used for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. Operated by physicians in a clinical setting, the device is inserted percutaneously to dilate the stenotic pulmonary valve. The catheter facilitates the mechanical expansion of the valve to improve blood flow. It is intended for patients with pulmonary stenosis. The device functions as a mechanical tool for valvuloplasty; it does not involve electronic processing, software, or AI/ML algorithms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous balloon catheter for valvuloplasty. Mechanical device; no energy source, software, or connectivity. Materials and construction consistent with standard percutaneous catheter specifications for cardiovascular use.

Indications for Use

Indicated for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in patients with isolated pulmonary stenosis or valvular pulmonary stenosis with minor congenital heart disease not requiring surgery.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 3 1 2012

NuMED Inc. c/o Ms. Nichelle LaFlesh Regulatory Affairs Manager/Compliance Officer 2880 Main Street Hopkinton, NY 12967

Re: K121859

Trade/Device Name: Tyshak NuCLEUS™ Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DOY Dated: July 31, 2012 Received: August 1, 2012

Dear Ms. LaFlesh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Nichelle LaFlesh

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

. Sincerely yours.

Cmdkille

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known): K121859

## Device Name: TYSHAK NuCLEUS™ CATHETER

Indications For Use:

This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

- 트 A patient with isolated pulmonary stenosis.
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mg. Killebrew

(Division Sian-Off) Division of Cardiovascular Devices

K121859 510(k) Number

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